TORONTO, Canada -- December 22, 2021 -- InvestorsHub NewsWire
-- Cybin Inc. (NEO:CYBN) (NYSE American:CYBN)
("Cybin" or the "Company"),
a biopharmaceutical company focused on progressing "Psychedelics to
Therapeutics™" is pleased to provide a year-end summary of its
major milestones and key catalysts from 2021 that it believes have
positioned the Company for a transformative 2022.
"2021 was an exciting year for Cybin. We expanded our
organization from 5 to more than 55 employees across 4 countries
and have established an operating ecosystem of nearly 50 partners
and vendors that have supported more than 90 preclinical studies
and numerous patent and investigational new drug filings over the
past 12 months," said Doug Drysdale, Cybin's Chief Executive
Officer. "Driven by promising and differentiating preclinical data,
our innovative operational and R&D pipeline platforms expect to
support 4 first-in-human clinical studies in 2022, which we hope
will progress our proprietary psychedelic development candidates
CYB003 and CYB004 closer toward potential approval for treating
depression and addiction disorders. We believe 2022 will be a truly
transformative year for Cybin."
2021 Business Highlights:
- Awarded Notice of Allowance from U.S. Patent and
Trademark Office for CYB004 (deuterated psychedelic
tryptamine) for the treatment of anxiety disorders;
- Confirmed Scientific Advice Meeting with UK Medical and
Healthcare Products Regulatory Agency for lead
candidate CYB003 for the treatment of major depressive disorder and
alcohol use disorder;
- Announced FDA Investigational New Drug and
Institutional Review Board Approvals for a co-funded
investigator-initiated Phase 2 clinical trial evaluating
psychedelic-assisted psychotherapy to treat frontline clinicians
experiencing COVID-related distress utilizing the EMBARK
psychedelic facilitator training program;
- Awarded Grant for Psychedelic Treatment
Clinic to Lenox Hill Hospital to benefit underserved
communities. Lenox Hill Hospital, part of Northwell Health is the
largest healthcare system in New York State;
- Announced Positive CYB003
Data demonstrating significant advantages over oral
psilocybin for the treatment of mental health disorders. The
Company's deuterated psilocybin analog from its CYB003 program
demonstrated a 50% reduction in variability compared to oral
psilocybin, a 50% reduction in dose compared to oral psilocybin, a
50% shorter time to onset when compared to oral psilocybin and
nearly double brain penetration when compared to oral
psilocybin;
- Granted a Schedule I Manufacturing License from the
U.S. Drug Enforcement Agency for the Company's
Boston-area research lab that is expected to allow the Company to
expand its internal research and development capabilities;
- Received Approval from FDA for its Investigational New
Drug Application to proceed with a Company-sponsored
feasibility study using the Kernel Flow quantitative neuroimaging
technology to measure ketamine's psychedelic effect on cerebral
cortex hemodynamics;
- Launched the EMBARK Psychedelic Facilitator Training
Program in collaboration with the University of
Washington in preparation for the first clinical trial of
psilocybin-assisted psychotherapy to address COVID-19 related
distress in frontline healthcare professionals;
- Completed 74 In-Vitro and In-Vivo
Evaluations of the Company's expanding portfolio of
psychedelic compounds being designed for potential therapeutic
applications for several mental health conditions. To date, more
than 50 novel compounds have been evaluated;
- Signed Drug Development Agreement with
Catalent which employs around 15,000 people,
including approximately 2,400 scientists and technicians, at more
than 45 facilities;
- Retained Former FDA Psychiatry Division Director Dr.
Thomas Laughren as a Clinical Advisory Board
Member;
- Expanded Operations into Europe and
announced the appointment of Dr. Amir Inamdar as Chief Medical
Officer for its European Operations;
- Became the First Psychedelic Company to
list on the NYSE American;
- Raised Nearly $70M through a bought-deal
offering and overnight market financing taking the total capital
raise since the company's inception to over $120M;
- Initiated Next Phase of Company's Digital Therapeutics
Platformwhich will better enable the evaluation of patient
outcomes through a highly secure, patient-centered data analytics
platform for better pre- and post-psychedelic treatments;
- Commenced Scale-Up of the Company's European Operations
and Research Activities with various academic and
clinical research organizations, including the transfer of its
intellectual property assets to its recently formed wholly-owned
Ireland subsidiary;
- Announced Alcohol Use Disorder and Anxiety Disorders as
New Target Indications alongside the Company's
previously announced major depressive disorder target
indications;
- Expanded patent
portfolio to cover, among other
things, novel psychedelic compounds,
integration of delivery platforms, methods of use in psychiatric
indications, drug discovery pipeline of modified and novel
ergolines, tryptamines and phenethylamines;
- Entered into Exclusive Research and Development
Collaboration agreement with TMS NeuroHealth Centers
Inc., a wholly-owned subsidiary of Greenbrook TMS Inc. (TSX:GTMS)
(NASDAQ:GBNH), which operates 129 outpatient mental health service
centers in the United States.
About Cybin
Cybin is a leading ethical biopharmaceutical company, working with
a network of world-class partners and internationally recognized
scientists, on a mission to create safe and effective therapeutics
for patients to address a multitude of mental health issues.
Headquartered in Canada and founded in 2019, Cybin is operational
in Canada, the United States, United Kingdom and Ireland. The
Company is focused on progressing Psychedelics to Therapeutics™ by
engineering proprietary drug discovery platforms, innovative drug
delivery systems, novel formulation approaches and treatment
regimens for mental health disorders. Patent filings described
herein are held by Cybin IRL Limited, a wholly owned subsidiary of
Cybin.
Cautionary Notes and Forward-Looking
Statements
Certain statements in this press release constitute forward-looking
information. All statements other than statements of historical
fact contained in this press release, including, without
limitation, statements regarding Cybin's future, strategy, plans,
objectives, goals and targets, and any statements preceded by,
followed by or that include the words "believe", "expect", "aim",
"intend", "plan", "continue", "will", "may", "would", "anticipate",
"estimate", "forecast", "predict", "project", "seek", "should" or
similar expressions or the negative thereof, are forward-looking
statements. Forward-looking statements in this news release include
statements regarding the Company's proprietary drug discovery
platforms, innovative drug delivery systems, novel formulation
approaches and treatment regimens to potentially treat psychiatric
disorders.
These forward-looking statements are based on reasonable
assumptions and estimates of management of the Company at the time
such statements were made. Actual future results may differ
materially as forward-looking statements involve known and unknown
risks, uncertainties, and other factors which may cause the actual
results, performance, or achievements of the Company to materially
differ from any future results, performance, or achievements
expressed or implied by such forward-looking statements. Such
factors, among other things, include: implications of the COVID-19
pandemic on the Company's operations; fluctuations in general
macroeconomic conditions; fluctuations in securities markets;
expectations regarding the size of the psychedelics market; the
ability of the Company to successfully achieve its business
objectives; plans for growth; political, social and environmental
uncertainties; employee relations; the presence of laws and
regulations that may impose restrictions in the markets where the
Company operates; and the risk factors set out in the Company's
management's discussion and analysis for the period ended September
30, 2021 and the Company's listing statement dated November 9,
2020, which are available under the Company's profile on
www.sedar.com and with the U.S. Securities and Exchange Commission
on EDGAR at www.sec.gov. Although the forward-looking statements
contained in this news release are based upon what management of
the Company believes, or believed at the time, to be reasonable
assumptions, the Company cannot assure shareholders that actual
results will be consistent with such forward-looking statements, as
there may be other factors that cause results not to be as
anticipated, estimated or intended. Readers should not place undue
reliance on the forward-looking statements and information
contained in this news release. The Company assumes no obligation
to update the forward-looking statements of beliefs, opinions,
projections, or other factors, should they change, except as
required by law.
Cybin makes no medical, treatment or health benefit claims about
Cybin's proposed products. The U.S. Food and Drug Administration,
Health Canada or other similar regulatory authorities have not
evaluated claims regarding psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds. The efficacy
of such products has not been confirmed by approved research. There
is no assurance that the use of psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds can diagnose,
treat, cure or prevent any disease or condition. Rigorous
scientific research and clinical trials are needed. Cybin has not
conducted clinical trials for the use of its proposed products. Any
references to quality, consistency, efficacy and safety of
potential products do not imply that Cybin verified such in
clinical trials or that Cybin will complete such trials. If Cybin
cannot obtain the approvals or research necessary to commercialize
its business, it may have a material adverse effect on Cybin's
performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock
exchange have approved or disapproved the contents of this news
release and are not responsible for the adequacy and accuracy of
the contents herein.
Contacts
Investor & Media:
Leah Gibson
Vice President, Investor Relations
Cybin Inc.
leah@cybin.com
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